Intubation devices, in general, are well known in the medical field. Tubes are often inserted into body passageways or cavities of a patient to ventilate, drain, and/or irrigate the cavity into which the tube is inserted. Continuing efforts are being made to design intubation devices that are easily and comfortably inserted into a patient, particularly when the tube must be left in place within the patient.
One medical use for an intubation device is in the treatment of maxillary sinusitis. Sinusitis is an inflammation of the sinuses caused, for example, by viruses, bacteria or an allergy. In the maxillary sinus, the inflammation causes an obstruction of the ostium or opening into the maxillary sinus and swelling of the lateral wall of the nose. To treat persistent sinusitis, the inflamed and obstructed maxillary sinus must be accessed for draining and irrigation.
According to one well known procedure known as antrotomy, the wall of the maxillary sinus is penetrated to allow the sinus to be treated. One way of penetrating the maxillary sinus is with an endoscopically guided trephine or rotating cutting tool. Following local anesthesia, an endoscope is inserted into the nasal cavity to observe the cavity and guide the cutting edge of the trephine to the desired location on the wall of the maxillary sinus, typically the thinnest bone surface. The cutting edge of the trephine is covered by a sheath known as a cannula to prevent mucosal irritation and bleeding. The cannula is used to raise the inferior turbinate bone, allowing the cutting edge of the trephine to access the wall of the maxillary sinus. The maxillary sinus can also be accessed by puncturing the sinus wall, although trephination is less painful and less disruptive.
Once the sinus wall has been penetrated, the endoscope is removed and the cannula is left in place to guide the intubation device into the cavity. Intubation allows the inflamed maxillary sinus to be drained, ventilated or irrigated. Intubation typically offers a rapid relief of pain and rhinorrhea, and prevents the need for further anesthesia and penetration through the sinus wall.
Existing intubation devices, however, still cause some discomfort and are also difficult to install and use. One type of existing tube must be fixed to the wall of the sinus by suturing which requires difficult surgical installation and causes discomfort to the patient. Other types of intubation devices are not accessible to the patient and do not allow the patient to perform their own irrigation. Conventional intubation devices are also not shaped and dimensioned to conform to the sinus wall and cavity and therefore cause discomfort and difficult breathing. Further, some existing intubation devices only allow drainage or irrigation of the sinus cavity and are not capable of allowing introducing medication into the maxillary sinus for treatment of sinusitis.
Accordingly, a need exists for an intubation device that is easily inserted into a maxillary sinus without suturing and with minimal discomfort to the patient. A need also exists for an intubation device designed to be comfortably left in place in the maxillary sinus, to be accessible by the patient or the surgeon without complex instrumentation, and to remain in place when breathing, sneezing, or blowing.